Covering the whole development process for the global biotechnology industry

Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.

Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.

Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.

Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.

Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.

A New Paradigm in Process Development:
To Accelerate Biologic Manufacturing of MAbs, Vaccines, and Novel Biotherapies

As the need to accelerate biopharmaceutical development around the world continues to grow, biomanufacturers face a host of challenges so they, too, can grow. Increasing process productivity, reducing cost, mitigating risk, and bringing products to market faster are just a few of the issues frequently addressed. But with support in process development, cGMP manufacturing and training, accelerating bioprocess development can become less challenging. Several biomanufacturers have successfully navigated these issues in collaboration with GE Healthcare’s Fast Trak Services. Whether it was through process and analytical development, process scale-up, or manufacturing of drug material for use in toxicology studies, recent collaborations have yielded remarkable results. This special report sponsored by GE Healthcare features case studies describing projects in which collaborative efforts resulted in fast resolutions to common biomanufacturing challenges.

Pfizer Collaborates to Accelerate Approval of Biosimilar MAbs in China
This case study describes how Pfizer is collaborating with GE Healthcare to achieve regulatory approval of biosimilars in China by streamlining process transfer strategies and implementing both single-use technologies and flexible, deployable manufacturing solutions.

Roivant Sciences Accelerates Process Development to Speed Orphan Therapy to Market
This case study shares the work of GE’s Fast Trak Services team to help accelerate development of a process for cGMP production of material for
toxicology studies. GE scientists worked closely with Roivant Sciences to facilitate tech transfer, and a cGMP manufacturing process was developed.

MAbxience Optimizes and Accelerates Downstream Biosimilar Process Development
With the aim of improving the first generation process to reach the manufacturability and purity required to produce material for phase 1 clinical trials, MAbxience contacted GE Healthcare’s Fast Trak Services team to initiate a collaborative project. This case study demonstrates the optimization of the downstream purification process to improve product purity and recovery of the biosimilar Fc-fusion protein.

Flavivirus Vaccine Production Accelerates with Modern Bioprocess Tools and Solutions
Cell-based vaccine production is traditionally performed in stainless steel bioreactors that require extensive cleaning and sterilization preparation time. Alternative single-use equipment minimizes the need for costly and time-consuming cleaning operations, minimizes cross-contamination risk, and contributes to increased operator safety by eliminating the need for open handling of products. This article outlines how a single-use equipment train from GE Healthcare helped accelerate flavivirus vaccine manufacturing.